A Controlled Clinical Trial of Local Anesthesia for Lumbar Punctures in Newborns

PEDIATRICS ◽  
1991 ◽  
Vol 88 (4) ◽  
pp. 663-669 ◽  
Author(s):  
Fran L. Porter ◽  
J. Philip Miller ◽  
F. Sessions Cole ◽  
Richard E. Marshall

To evaluate the efficacy of subcutaneous administration of lidocaine for reducing physiologic instability in acutely ill newborns during clinically required procedures, 81 neonates who required lumbar punctures within the first month of life were stratified by birth weight and respiratory support and randomly assigned to an experimental or a control group. The experimental group received an injection of 0.1 mL/kg of 1% lidocaine prior to the lumbar puncture. The control group received a nonanesthetized lumbar puncture without placebo. Changes in heart rate, respiratory rate, transcutaneous oxygen and carbon dioxide tensions, and heart rate variability from baseline, preparatory (positioning/handling), lumbar puncture, and recovery periods were measured. The administration of lidocaine did not minimize physiologic instability in response to the lumbar puncture nor was it associated with any detectable adverse effects other than prolonging the duration of the lumbar puncture. Although significant physiologic changes were observed in response to preparatory procedures, few additional changes beyond those occurred in response to lumbar punctures in either the experimental or control group. It is concluded that local anesthesia failed to influence manifestations of physiologic instability during neonatal lumbar punctures and that preparatory procedures were more destabilizing than either the administration of lidocaine or the lumbar puncture itself. The results suggest that the management of newborns requires emphasis on minimizing the destabilizing effects of required and frequent handling procedures.

PEDIATRICS ◽  
1992 ◽  
Vol 89 (5) ◽  
pp. 976-976
Author(s):  
JOAQUIM M.B. PINHEIRO

To the Editor.— In "A Controlled Clinical Trial of Local Anesthesia for Lumbar Punctures in Newborns"1 Porter et al reported on their attempt to decrease lumbar puncture-induced physiologic instability by using lidocaine. While the cardiorespiratory measures of physiologic instability were not affected by local anesthesia, they were influenced significantly and adversely by the preparatory procedure (ie, being held flexed in the fetal position). As pointed out by the authors, the position chosen for the procedure, which included knees to chest plus flexion of head and neck has been shown to induce more adverse physiologic responses than either the sitting or the modified lateral (neck not flexed) position.2,3


2020 ◽  
Vol 11 ◽  
Author(s):  
Ju Hyun Lee ◽  
Eun Heui Jo ◽  
Jee Youn Jung ◽  
Young-Eun Kim ◽  
Mi-Ju Son ◽  
...  

Atopic dermatitis is a chronic inflammatory skin disease that affects the growth and development of children. The prevalence of atopic dermatitis has been continually increasing, and this has also been accompanied by rising socioeconomic costs. Interest has been growing in alternative medicine as a means of alleviating the burden of atopic dermatitis. This was a single-center, double-blinded, randomized, placebo-controlled investigator-led clinical trial including 60 atopic dermatitis patients. The participants were classified into an experimental group (30 persons) and a control group (30 persons), who were administered, respectively, socheongryong-tang or a placebo for 4 weeks. After 4 weeks of treatment, the participants visited the trial center again and assess their efficacy and safety. The researchers performed statistical comparisons of the changes in the SCORAD Index, amount and frequency of ointment use, and height and weight to assess the efficacy. To assess the safety, diagnostic tests and vital sign checks were performed at each visit, and the presence or absence of adverse events was observed. As a result, the frequency and the amount of steroid ointment application in both groups increased, but the experimental group showed less tendency (p = 0.081). Results of analyzing the children in the experimental group in relation to growth showed a significantly greater height growth than the control group (p < 0.05). In addition, all study participants did not show any remarkable abnormal signs in the safety evaluation. In conclusion, compared to the control group, the experimental group, who took socheongryong-tang showed a tendency to be less dependent on steroid ointment and statistically significant increase in height.


2021 ◽  
Author(s):  
Chao-ran Bi ◽  
Jing Wei ◽  
Xiao-fei Xie ◽  
Yan-jing Liu

Abstract Background: Bacterial infection is an important cause of diarrhea in children, potentially leading to malnutrition, growth and development disorders, and even death. Antibiotic abuse and resistance are widespread problems worldwide, especially in China. We therefore designed a study to evaluate the clinical efficacy and mechanism of traditional Chinese medicine in alleviating the effects of antibiotic resistance in childhood bacterial diarrhea and enhancing the sensitivity of pathogenic bacteria to antibiotics.Methods: This randomized, double-blind, placebo-controlled clinical trial has completed ChiCTR registration. The trial will randomly divide 120 children who meet the inclusion criteria into three groups: experimental group 1 (basic treatment + Gegen Qinlian decoction granules + Erbai drink placebo); experimental group 2 (basic treatment + Erbai drink granules + Gegen Qinlian decoction placebo); and control group (basic treatment + Gegen Qinlian decoction placebo + Erbai drink placebo). The main efficacy indicators will be antibiotic use rate and clinical cure rate, and the secondary efficacy indicators will be time to antibiotic intervention, effective rate, and course of treatment determined after 5 days. The following physical and chemical indicators will be measured: routine blood parameters, procalcitonin, C-reactive protein, electrocardiogram, liver and kidney function, electrolytes, routine urinalysis, routine stool analysis, and stool culture (including drug sensitivity). Discussion: The results of this study may provide an objective clinical basis for the use of traditional Chinese medicine in managing antibiotic-resistant bacterial diarrhea in children, formulating relevant guidelines, and demonstrating the use of traditional Chinese medicine for reducing the use of antibiotics.Trial registration: Chinese Clinical Trial Registry, ChiCTR1900027915. Date of last refreshed on 12/4/2019, http://www.chictr.org.cn/index.aspx.


Author(s):  
Manuela de Mendonça Figueirêdo Coelho ◽  
Luciana Catunda Gomes de Menezes ◽  
Shérida Karanini Paz de Oliveira ◽  
Ana Débora Alcantara Coêlho Bonfim ◽  
Viviane Mamede Vasconcelos Cavalcante ◽  
...  

Objective: to evaluate the rate of healing in diabetic foot ulcers treated with a biomembrane of latex proteins from Calotropis procera (BioMem CpLP) when compared to powdered hydrocolloid. Method: randomized controlled clinical trial, registered by the Brazilian Clinical Trial Registry (REBEC), according to protocol RBR-98f3j9, carried out with eight people with diabetic foot, in a diabetic foot clinic, from March to July 2019. In the experimental group (n = 04), biomembrane was applied; in the control group (n = 04), hydrocolloid powder was used. The healing rate was assessed at 30 and 60 days after starting treatment. Results: no statistical differences were found between the healing rates of the control group and the experimental group in the temporal analysis of the initial 30 days (p = 0.726) and in the 60 days following the start of treatment (p = 0.562). Conclusion: BioMem CpLP presented healing rates similar to the conventional product, being an effective and low cost alternative for the treatment of diabetic feet.


Rev Rene ◽  
2020 ◽  
Vol 21 ◽  
pp. e43904
Author(s):  
Tamires Rebeca Forte Viana Viana ◽  
Gleicia Martins de Melo ◽  
Maria Vera Lucia Moreira Leitão Cardoso ◽  
Paulo César de Almeida ◽  
Lusiana Moreira de Oliveira ◽  
...  

Objective: to compare pain scores in term newborns submitted to music and swaddling interventions during venipuncture. Methods: pilot study of a clinical trial, carried out with 11 newborns in rooming-in care who received venipunctures. The newborns were randomly allocated into two groups: Experimental (20 minutes of music + swaddling) and Control (swaddling). Newborns were filmed and pain was assessed by the Neonatal Facial Coding System at baseline, procedure, and initial recovery phases. Results: the Experimental Group at baseline, procedure (antisepsis, puncture, and milking), and recovery showed less pain reactions and lower heart rate mean and variation (p<0.05) than the Control Group. Conclusion: newborns who received the intervention of music combined with swaddling had less pain reactions and less variations in heart rate during venipuncture. Brazilian Clinical Trial Registry: RBR-8x8v2r.


2019 ◽  
Vol 8 ◽  
pp. 1350
Author(s):  
Maryam Hassanzad ◽  
Keyvan Maleki Mostashari ◽  
Hosseinali Ghaffaripour ◽  
Habib Emami ◽  
Samane Rahimi limouei ◽  
...  

Background: We examined the efficiency and safety of a specific synbiotic compound, brand name Kidilact®, in the treatment of asthma in children 12 years of age or younger. Materials and Methods: This double-blinded, randomized, placebo-controlled clinical trial was conducted in Tehran, Iran, from May 22, 2016, to May 21, 2017. One hundred children, 12 years of age or younger, who suffered from mild to moderate asthma were recruited in this study. The subjects were randomly divided into two groups; the experimental group received a sachet of Kidilact®, and the control group received a sachet of placebo once a day for six months. Both groups were compared in terms of the frequency of asthma attacks that were severe enough to require administration of fast-acting medications, the number of outpatient visits for asthma-related problems, and the frequency of hospitalization due to exacerbated symptoms of asthma. Results: There were fewer complaints of drug-induced side effects, e.g., vomiting, headache, stomachache, and diarrhea, exacerbated cough, and constipation in the experimental group than in the control group. Overall, a significantly greater number of participants in the experimental group were satisfied with the therapeutic intervention than those in the control group, as verified by the participants and their parents/guardians self-report. There was no significant difference between both groups in the frequency of asthma attacks and hospitalization due to exacerbated symptoms of asthma. The only significant difference between both groups was the count of outpatient visits. While the control group made 55 outpatient visits to the hospital, participants in the experimental group visited the hospital only 19 times (P=0.001). Conclusion: Results of our study indicates that synbiotic compound Kidilact® generally alleviates the symptoms of asthma in children of 12 years of age or younger, resulting in less frequent outpatient visits to the hospital due to asthma-related problems while rarely causing any side effects. Due to ease of use, the rarity of side effects, and their indirect positive effects on quality of life of asthmatic patients, we recommend that synbiotics be incorporated in regular treatment and management of children with asthma. [GMJ.2019;8:e1350]


2019 ◽  
Vol 53 (4) ◽  
Author(s):  
Elizabeth R. Paterno ◽  
Clarisse A. Pangilinan ◽  
Erna C. Arollado ◽  
Rachael Marie B. Rosario

Objective. The study determined the safety, efficacy and acceptability of a Philippine community preparation of Siling Labuyo liniment in the management of knee osteoarthritis. Methods. A 6-week randomized, double-blind, active-controlled clinical trial was conducted in three municipalities of Cavite from 2017-2018. The municipalities were randomly assigned to either the control or experimental group, using a commercially available Diclofenac 1% gel as the control agent. Knee Injury and Osteoarthritis Outcome Score (KOOS) and Pain Visual Analogue Scale (VAS) were used to measure the outcomes. Results. Forty-seven participants completed the study. Statistically significant improvement (p<0.05) in pain relief, reduction of symptoms and increase in knee functionality was reported by participants in both the experimental and control groups. Across the dimensions measured, at least 30% improvement in scores was reported by the experimental group, and at least 40% by the control group. The difference was statistically not significant (p>0.05). Itching (13%), burning sensation (11%) and reddening of the skin (15%) were experienced in both the experimental and the active control groups. Conclusion. Use of the liniment led to a modest therapeutic effect and was well-tolerated by the participants.


2019 ◽  
Vol 37 (2) ◽  
Author(s):  
Zinat Mohebb ◽  
Setareh Fazel Dehkordi ◽  
Farkhondeh Sharif ◽  
Ebrahim Banitalebi

Abstract Objective. This work sought to determine the effectiveness of an aerobic exercise program on the occupational stress of nurses.Methods. Prevention-type controlled clinical trial carried out with the participation of 60 nurses working in hospitals affiliated to Shahrekord University of Medical Sciences in Iran. Randomly, the nurses were assigned to the experimental group or to the control group. The intervention consisted in an aerobic exercise program lasting three months with three weekly sessions one hour each. The Health and Safety Executive (HSE) questionnaire measured occupational stress with 35 questions, each with five Likert-type response options, which can have a maximum score of 175 points; higher scores meant lower levels of occupational stress. The HSE was evaluated during three moments: upon registering, after finishing the exercise program (week 8), and two months after terminating the intervention (week 16).Results. The level of occupational stress was the same in the experimental and control groups during registration (86.2 vs. 86.3). Upon finishing the aerobic exercise program (week 8), the experimental group showed a higher score than the control group (119.7 vs. 86.2, p<0.01), with this score diminishing after two months of having ended the intervention (91.4 vs. 85.8, p=0.061).Conclusion. The aerobic exercise program was associated to decreased work stress of nurses in the experimental group compared to the control group at eight weeks, but this difference did not persist when the experimental group did not continue with the program.Descriptors: control groups; physical exertion; occupational stress; nurses; female.How to cite this article: Zinat Mohebbi Z, Dehkordi SF, Sharif S, Banitalebi E. The Effect of Aerobic Exercise on Occupational Stress of Female Nurses: A Controlled Clinical Trial. Invest. Educ. Enferm. 2019; 37(2):e05.ReferencesRice PL. Stress and health. Brooks/Cole Publishing Company. 3rd Ed. 1998. Mashhadi HA, Arizi HR. A comparsion of job motivation trends among teachers of handicaped and public schools. Amuzeh. 2011; 6(3):18-32. Sarafis P, Rousaki E, Tsounis A, Malliarou M, Lahana L, Bamidis P, et al. The impact of occupational stress on nurses' caring behaviors and their health related quality of life. BMC Nurs. 2016; 15:56. Bhui K, Dinos S, Galant-Miecznikowska M, de Jongh B, Stansfeld S. Perceptions of work stress causes and effective interventions in employees working in public, private and non-governmental organisations: a qualitative study. BJPsych. Bull. 2016; 40(6):318-25. Lo MC, Thurasamy R, Liew WT. Relationship between bases of power and job stresses: role of mentoring. Springerplus. 2014; 3:432. Trifunovic N, Jatic Z, Kulenovic AD. Identification of Causes of the Occupational Stress for Health Providers at Different Levels of Health Care. Med Arch. 2017; 71(3):169-72. Montano D, Hoven H, Siegrist J. Effects of organisational-level interventions at work on employees’ health: a systematic review. BMC Public Health. 2014: 14(1):135. Van den Oetelaar WF, van Stel HF, van Rhenen W, Stellato RK, Grolman W. Balancing nurses' workload in hospital wards: study protocol of developing a method to manage workload. BMJ Open. 2016;6(11):e012148. Roberts RK, Grubb PL. The consequences of nursing stress and need for integrated solutions. Rehabil. Nurs. 2013; 39(2):62-9. Sharma P, Davey A, Davey S, Shukla A, Shrivastava K, Bansal R. Occupational stress among staff nurses: Controlling the risk to health. Indian J. Occup. Environ. Med. 2014; 18(2):52-6. Nabirye RC, Brown KC, Pryor ER, Maples EH. Occupational stress, job satisfaction and job performance among hospital nurses in Kampala, Uganda. J. Nurs. Manag. 2014; 19(6):760- 8. Isfahani S, Hosseini M, Khoshknab H, Peyrovi, Khanke R. What Really Motivates Iranian Nurses to Be Creative in Clinical Settings?: A Qualitative Study. Glob. J. Health Sci. 2015; 7(5): 132-58. Taghavi Larijani T, Ramezani F, Khatoni A, Monjamed Z. Comparison of the sources of stress among the senior Nursing and Midwifery Students of Tehran Medical Sciences Universities. Hayat. 2007; 13(2):61-70. Brunner L, Suddarth D. CanadianTextbook of medical surgical nursing. 14th Ed. Lippincott Williams & Wilkins; 2017. Rees R, J Kavanagh J, Harden A, Shepherd J, Brunton G, Oliver S, Oakley A. Young people and physical activity: a systematic review matching their views to effective interventions. Health Educ. Res. 2006; 21(6):806–25. Mogharnasi M, Koushan M, Golestaneh F, Seyedahmadi M, Keavanlou F. The Effect of Aerobic Training on the Mental Health of Addict Women. J. Sabzevar Univ. Med. Sci. 2011; 18(2):7-91. Guszkowska M. Effect of exercise on anxiety, depression and mood. Psychiatr. Pol. 2004; 38(4):611-20. [Polish] Min JA, Lee CU, Lee C. Mental health promotion and illness prevention: a challenge for psychiatrists. Psychiatry Investig. 2013;10(4):307-16. Dehghani H, Farmanbar R, Pakseresht S, Kazem Nezhad Leili E. Effect of regular exercise on methods of problem centered stress coping mechanism. J. Holist. Nurs. Midwifery. 2012; 22(2):33-9. Boyce RW, Ciulla S, Jones GR, Boone EL, Elliott SM, Combs CS. Muscular Strength and Body Composition Comparison Between the Charlotte-Mecklenburg Fire and Police Departments. Int. J. Exerc. Sci. 2008; 1(3):125-35. Marzabadi A, Gholami FM . Reliability and Validity Assessment for the HSE Job Stress Questionnaire. J. Behav. Sci. 2011; 4(4):291-97. Cooke M, Holzhauser K, Jones M, Davis C, Finucane J. The effect of aromatherapy massage with music on the stress and anxiety levels of emergency nurses: comparison between summer and winter. J. Clin. Nurs. 2007; 16(9):1695-703. Somero GN. The physiology of global change: linking patterns to mechanisms. Ann. Rev. Mar Sci. 2012; 4: 39–61. Abedian Z, Safaei M. The effect of performance exercise on stress in midwives: A clinical trial. Iran. J. Obstet. Gynaecol. Infertil. 2014; 17(96): 14-20. Ayatinasab K, Esmaeilzadeh M, Sangsefidi S, The effect of aerobic and yoga exercise on Self-efficacy of female staff of Sabzevar University of Medical Sciences in 2013. J Sabzevar Univ. Med. Scie. 2014; 20(5):590-6.


2019 ◽  
Vol 37 (3) ◽  
Author(s):  
Khatereh Rostami ◽  
Fariba Ghodsbin

Objective. The work, herein, sought to determine the effect of yoga on the quality of life of nurses working in intensive care units (ICU). Methods. This was a randomized controlled clinical trial of a preventive intervention of three weekly sessions of yoga exercises, which included aspects of meditation, breathing control, and slow body movements. The study selected 70 nurses working in ICU and assigned them to two groups: experimental (n = 35) and control (n = 35). The World Health Organization Quality of Life brief questionnaire (WHOQoL-Bref) was used to evaluate on four moments (baseline, one, two, six months after the start of the study); this scale has 26 items with Likert-type response options ranging from 1 to 5; higher total score indicates better quality of life. Results. The baseline score of quality of life in the experimental group was 62.3, which increased to 70.7 on the first month and continued improving in the evaluations on the second month (72.8) and sixth month (74.1), with this change being statistically significant. Instead, the control group showed no differences in scores of the different moments of evaluation (baseline = 62, first month = 61.9, second month = 62.4, and sixth month = 60.4). In the four domains of the WHOQoL-Bref (physical, psychological, social relationships, and environment), it was also noted that the experimental group obtained better scores over time compared with the control group. Conclusion. The intervention of yoga exercises was effective in improving the quality of life of nurses working in ICU.Descriptors: yoga; exercise; meditation; nurses; quality of life; intensive care units; randomized controlled trial; surveys and questionnaires; encuestas y cuestionarios.How to cite this article: Rostami K, Ghodsbin F. Effect of Yoga on the Quality of Life of Nurses Working in Intensive Care Units. Randomized Controlled Clinical Trial. Invest. Educ. Enferm. 2019; 37(3):e06.


2008 ◽  
Vol 5 (3) ◽  
pp. 325-328 ◽  
Author(s):  
Myung-Haeng Hur ◽  
Yun Seok Yang ◽  
Myeong Soo Lee

This study investigated the effects of aromatherapy massage on menopausal symptoms in Korean climacteric women. Kupperman's menopausal index was used to compare an experimental group of 25 climacteric women with a wait-listed control group of 27 climacteric women. Aromatherapy was applied topically to subjects in the experimental group in the form of massage on the abdomen, back and arms using lavender, rose geranium, rose and jasmine in almond and primrose oils once a week for 8 weeks (eight times in total). The experimental group reported a significantly lower total menopausal index than wait-listed controls (P< 0.05). There were also significant intergroup differences in subcategories such as vasomotor, melancholia, arthralgia and myalgia (allP< 0.05). These findings suggest that aromatherapy massage may be an effective treatment of menopausal symptoms such as hot flushes, depression and pain in climacteric women. However, it could not be verified whether the positive effects were from the aromatherapy, the massage or both. Further rigorous studies should be done with more objective measures.


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